MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY 2; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T165

Device Problems Pacing Problem (1439); Device Operates Differently Than Expected (2913)

Patient Problems Heart Failure (2206); Complaint, Ill-Defined (2331)

Event Date 09/23/2012

Event Type  malfunction  

Event Description

Additional information was received indicating that a revision procedure was performed wherein the device was explanted and successfully replaced.Moreover, the left ventricular (lv) port was plugged as the patient¿s left side access was blocked.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

Boston scientific received information that during device check for recent patient admission, it was found out that the device reached end of life (eol) a year ago due to charge time issue.Furthermore, this device exhibited pacing inhibition and has now reverted to storage mode; however, a replacement has not been determined at this time.Additional information was received indicating that due to health issues, the physician opted to discharge the patient home with a life vest until such time that the device can safely be replaced with minimal risk of infection.At this time, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

--.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, right ventricular pacing, and sensing functions were tested.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: VITALITY 2
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3734364
• MDR Text Key: 4493191
• Report Number: 2124215-2014-06565
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2007
• Device Model Number: T165
• Other Device ID Number: VITALITY 2 DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 04/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/09/2014; 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: T165; 0184; 4469
• Patient Age: 63 YR